Impulse Dynamics has grabbed a $30 million cash infusion as it nears data from a pivotal U.S. trial for its chronic heart failure (CHF) device. It's already marketed in Europe and been implanted in more than 3,000 patients.
The Optimizer IVs implantable device is designed to treat the estimated 70% of advanced CHF patients who remain symptomatic even with drug-based treatment, but are not eligible for cardiac resynchronization therapy because they have normal heart beat intervals. It's the only device marketed to do so, according to the company; it first received a CE mark in 2013.
"There is a significant need for a device-based technology that can offer symptom relief to heart failure patients who no longer respond to optimal medical therapy," said Dr. Peter Lee Ka Kit, vice chairman of Henderson Land Development, in a statement. "The Optimizer device is a unique technology that addresses this unmet need. We look forward to supporting Impulse in its commercial and clinical efforts globally and specifically in the Chinese market." His fund led the financing.
It works by sensing the heart's electrical activity. The device is about the size of a defibrillator and delivers cardiac contractility modulation (CCM) signals via two electrodes placed in the heart's right ventricle just after the heart contracts. These nonexcitatory electric pulses trigger biochemical and neurohormonal changes in the myocardium with no increase in oxygen consumption, thereby enabling the heart to work more efficiently.
A U.S. pivotal trial of the Optimizer System in 230 patients is slated to have primary outcome data in June, according to Clinicaltrials.gov. It consists of a treatment arm that will also continue on medication, as well as a control arm with just medication.
On the financing, Impulse Dynamics CEO Dr. Simos Kedikoglou said, "It is a reaffirmation of the value of CCM therapy for patients and healthcare systems globally. CCM is a well-established technology that meets a major need. Our lead investor in this round will play a crucial role in making CCM technology more widely available to heart failure patients especially in China."
Founded in 1996 by Israeli medical device entrepreneur Shlomo Ben-Haim, the startup has offices in Germany, the Netherlands and New Jersey.
- here is the release